Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT02546297

Collaborator

(none)

Enrollment

Location

Arms

41.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine which treatment is more effective and safer for the patients in COPD C group with bronchiectasis.The research results will help guide physicians to select appropriate individualized treatment and hopefully provide some evidence-based medicine proofs for revising guide.

Condition or Disease	Intervention/Treatment	Phase
COPD Bronchiectasis	Drug: Symbicort Drug: Spiriva	Phase 4

Detailed Description

The diagnosis and treatment of COPD and bronchiectasis together seems to be more complicated than the diagnosis and treatment of either condition alone. According to the GOLD，there are three treatments for patients with COPD in group C: ICS combined with LABA or LAMA alone or LABA combined with LAMA. However, it has not yet been demonstrated about which method is more effective for the patients with COPD in group C and bronchiectasis.

This study is designed as a prospective, randomized, case-control trial. Patients are divided into three groups, one group inhaled with ICS and LABA (Symbicort), the second group inhaled with LAMA (Tiotropium Bromide) and the third group inhaled with LAMA(Tiotropium Bromide) and (Symbicort).The course of treatment is 12 months.

The investigators will also assess other relevant outcomes, including the quality of life (QOL) score, pulmonary function test and the incidence of adverse event.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Comparisons of the Efficacy and Safety of Inhaled LAMA or LAMA+LABA or ICS+LABA for Patients in COPD C Group With Bronchiectasis

Actual Study Start Date :

Sep 15, 2017

Anticipated Primary Completion Date :

Sep 15, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ICS/LABA Group Symbicort，Inhalation，Individualized medication，12 months.	Drug: Symbicort drug are used for 12 months Other Names: Budesonide/Formoterol
Active Comparator: LAMA Group Tiotropium Bromide，Inhalation,Individualized medication，12 months.	Drug: Spiriva drug are used for 12 months Other Names: Tiotropium Bromide
Active Comparator: LAMA+LABA Group Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.	Drug: Symbicort drug are used for 12 months Other Names: Budesonide/Formoterol Drug: Spiriva drug are used for 12 months Other Names: Tiotropium Bromide

Arm

Intervention/Treatment

Active Comparator: ICS/LABA Group

Symbicort，Inhalation，Individualized medication，12 months.

Drug: Symbicort

drug are used for 12 months

Other Names:

Budesonide/Formoterol

Active Comparator: LAMA Group

Tiotropium Bromide，Inhalation,Individualized medication，12 months.

Drug: Spiriva

drug are used for 12 months

Other Names:

Tiotropium Bromide

Active Comparator: LAMA+LABA Group

Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.

Drug: Symbicort

drug are used for 12 months

Other Names:

Budesonide/Formoterol

Drug: Spiriva

drug are used for 12 months

Other Names:

Tiotropium Bromide

Outcome Measures

Primary Outcome Measures

Acute exacerbation [12 months]
The times of acute exacerbation during the trial.

Secondary Outcome Measures

Number of patients with adverse events [12 months]
All of the adverse events occurred in the processing of the trial,especially the prevalence of pneumonia.
FEV1 [12 months]
Forced Expiratory Volume in one second
FVC [12 months]
Forced Vital Capacity
FEV1/FVC [12 months]
Pulmonary function test
SGRQ [12 months]
St. George's Respiratory Questionnaire
LCQ [12 months]
The Leicester Cough Questionnaire
CAT [12 months]
COPD Assessment Test
mMRC [12 months]
Modified Medical Research Council Dyspnea Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients are suitable for inclusion in the study when they are 18 years or older diagnosed with COPD C group and bronchiectasis.

Exclusion Criteria:

active tuberculosis
severe respiratory disease (such as Lung cancer, ARDS, pulmonary encephalopathy, respiratory failure)
uncontrollable diabetes
hypersensitivity to any components of ICS/LABA or LAMA.